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The FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.

The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Microwave Generator into the target tissue. The FLEX 10 Accessory is a sterile, hand-held, single-use, surgical ablation device. The ablative microwave energy emanates from an antenna contained in the ablation sheath at the distal end of the device.

The FLEX 10 Accessory has a flexible 2 m long insulated coax cable that attaches the Probe to the Microwave Generator output cable. The flexible cable is attached to a 24 cm long hand grip, followed by a 15 cm section of stainless steel hypotube, followed by a highly flexible PTFE ablation sheath, which contains the movable microwave energy delivery antenna. The end of the ablation sheath is attached to a PEBAX positioning sheath and sutures to aid in the proper placement of the ablating sheath. Moving the sliding ring on the hand grip moves the antenna to discrete numbered locations in the ablating sheath. The position of the antenna within the ablating sheath is displayed to the user by the position indicator of the sliding ring on the hand grip.

The provided document is a 510(k) premarket notification for a medical device called the "FLEX 10 Accessory for the AFx Microwave Ablation System." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.

Therefore, the information required to populate most of the requested table and answer the study-related questions is not present in this document. This typically occurs because 510(k) clearances, especially for accessories to existing systems, often rely on bench testing and comparisons to established devices and their known performance, rather than new, extensive clinical trials with detailed statistical endpoints.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable/Not provided. The document mentions "animal testing" but does not specify the number of animals or the details of the study design.
• Data provenance: Not explicitly stated. Animal testing, typically pre-clinical, would precede human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. There is no mention of expert-established ground truth for a test set, as this isn't a diagnostic or imaging device study requiring such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is an ablation probe, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical surgical accessory; it does not operate as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated in detail for the "animal testing." The study objective was to demonstrate the "reliability of the sliding antenna concept," suggesting performance related to proper function and tissue ablation, which would likely be assessed through pathological examination of ablated tissue, but this is an inference.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable.

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